Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Manager Biostatistician (Manager, Biostats)

Sun Pharma
Sun Pharma
3-5 years
preferred by company
Gurgaon, Remote, India, India
1 May 13, 2026
Job Description
Job Type: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding

Job Title: Manager Biostatistician (Manager, Biostats)

Company: Sun Pharma
Location: Gurugram, India (Remote / Hybrid)
Business Unit: Global Clinical Development
Employment Type: Full-Time
Industry: Biostatistics / Clinical Development / Pharmaceutical R&D / Regulatory Statistics

Job Overview

We are hiring a Manager Biostatistician to lead statistical design, clinical trial analytics, regulatory biostatistics, data strategy, and scientific interpretation for registration-directed clinical development programs.

This role is ideal for professionals with expertise in clinical biostatistics, statistical methodology, drug development, regulatory submissions, statistical programming collaboration, and pharmaceutical clinical research analytics.

The successful candidate will support end-to-end clinical development programs from protocol design through regulatory submissions while partnering with cross-functional teams globally.


Key Responsibilities

Clinical Trial Statistical Design

Lead development of statistically robust trial strategies.

Responsibilities include:

  • Statistical study design
  • Protocol statistical input
  • Endpoint strategy support
  • Methodology selection
  • Analysis framework definition

Ensure designs are:

  • Scientifically sound
  • Regulatory acceptable
  • Strategically aligned
  • Data-efficient

Support programs across:

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

Statistical Analysis Plan (SAP) Leadership

Develop and oversee:

  • Statistical Analysis Plans (SAPs)
  • Analysis procedures
  • Statistical specifications
  • Methodological standards

Ensure protocol objectives are translated into executable analysis strategies.


Database & Data Strategy Collaboration

Partner with:

  • Data sciences
  • Statistical programming
  • Clinical stakeholders
  • Project teams

Responsibilities include:

  • Data collection strategy
  • Database implementation review
  • Project-specific data standards
  • Data monitoring support
  • Analysis readiness governance

Ensure high-quality, analysis-ready datasets.


Statistical Analysis Execution

Lead statistical analysis activities including:

  • Planned analyses
  • Exploratory analyses
  • Novel analytical approaches
  • Sensitivity analyses
  • Clinical data interpretation

Responsibilities:

  • Provide implementation guidance
  • Ensure methodological rigor
  • Improve analytical efficiency and sensitivity

Statistical Innovation

Apply advanced statistical thinking to:

  • Novel methodology development
  • Design optimization
  • Efficiency improvements
  • Enhanced study sensitivity
  • Better clinical interpretation

Support methodological innovation in development programs.


Scientific Reporting & Publications

Support statistical quality for:

  • Clinical study reports
  • Scientific reports
  • Regulatory summaries
  • Publications
  • Oral presentations
  • Project communications

Ensure:

  • Scientific accuracy
  • Clear interpretation
  • Statistical integrity
  • High-quality presentation

Cross-Functional Project Leadership

Partner with:

  • Clinical development
  • Regulatory affairs
  • Statistical programming
  • Data sciences
  • Functional leadership
  • Global study teams

Responsibilities:

  • Biostatistics representation on project teams
  • Development strategy contribution
  • Communication alignment
  • Project prioritization support

Training & People Leadership

Train and mentor statistical staff on:

  • Methodology
  • Operations
  • Best practices
  • Emerging statistical approaches

Support:

  • Internal capability building
  • Technical knowledge development
  • Scientific learning

For people managers:

  • Manage direct reports
  • Support recruitment
  • Enable team development

Regulatory Support

Support global regulatory activities including:

  • Regulatory submission document review
  • Statistical submission support
  • Agency interaction participation
  • Regulatory compliance activities

Preferred exposure:

  • NDA submissions
  • BLA submissions
  • eCTD submission environments

Software Validation & Compliance

Support validation and compliant use of statistical tools.

Responsibilities:

  • External software validation
  • SOP compliance
  • Regulatory standards alignment
  • Statistical governance adherence

Ensure compliance with:

  • GxP
  • Corporate policies
  • Department standards
  • Statistical operating procedures

Required Qualifications

Education

Preferred educational background:

  • Biostatistics
  • Statistics
  • Mathematics
  • Related quantitative disciplines

Experience Required

Relevant pharmaceutical clinical biostatistics experience preferred.

Strong understanding of:

  • Clinical development
  • Statistical trial methodology
  • Regulatory analytics

Preferred Therapeutic Experience

Exposure to:

  • Dermatology
  • Oncology